Health product recall

Syncvision System

Last updated

Summary

Product
Syncvision System
Issue
Medical devices - Inaccurate test or measurement results
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products Lot or serial number Model or catalog number
Syncvision System Not applicable 400-0100.10

Issue

If prior to the IFR/FFR pullback on the intrasight system, FFR measurement(s) were performed within the same syncvision procedural session, the co-registered distal value will be different than the distal value displayed in the philips IFR/FFR system. This error will appear "insufficient data, distal segment is not co-registered" the risk of suboptimal patient treatment due to falsely elevated data on the initial trendline for the IFR/FFR co-registration would be greatest from inexperienced interventionalists.

Recall start date: Dec 10, 2021

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies

Company: Philips Electronics Ltd.

1875 Buckhorn Gate, Mississauga, Ontario

Canada, L4W 5P1

Company: Volcano Corporation

3721 Valley Centre Drive, Suite 500, San Diego, California

United States, 92130

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63766

Get notified

Receive notifications for new and updated recalls and alerts by category.

Subscribe